FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MILLENNIUM
K Number: K980585
·
Decision Oct 8, 1998
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
260
Applicant Total
31
Review Days
233
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MILLENNIUM
- K Number
- K980585
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biolase Technology, Inc.
- Date Received
- February 17, 1998
- Decision Date
- October 8, 1998
- Product Code
- EFB
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EFB), ordered by most recent decision date.
High speed air turbine handpiece
FDA 510(k)
FDA Class 1
·Dental
Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)
FDA 510(k)
FDA Class 1
·Dental
Synea Fusion Handpieces (Intensiv & Profin)
FDA 510(k)
FDA Class 1
·Dental
Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
FDA 510(k)
FDA Class 1
·Dental
High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)
FDA 510(k)
FDA Class 1
·Dental
Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Biolase Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K122368 | WATERLASE IPLUS ALL TISSUE LASER | May 2, 2013 | Substantially Equivalent |
| K130465 | EPIC 10S | Apr 11, 2013 | Substantially Equivalent |
| K121327 | DIOLASE 10S | Feb 1, 2013 | Substantially Equivalent |
| K121286 | EPIC 10 | Sep 28, 2012 | Substantially Equivalent |
| K101658 | WATERLASE MD TURBO PLUS MODEL 7200XXX | Aug 11, 2010 | Substantially Equivalent |
| K093852 | EZLASE 3 LASER SYSTEM | Mar 12, 2010 | Substantially Equivalent |
| K091746 | WATERLASE MD, MODEL 7100102 | Dec 7, 2009 | Substantially Equivalent |
| K083927 | WATERLASE MD | Oct 1, 2009 | Substantially Equivalent |
| K091922 | WATERLASE C100, MODEL 7100104 | Jul 14, 2009 | Substantially Equivalent |
| K083595 | EZLASE | Apr 14, 2009 | Substantially Equivalent |